Standards Documents

List of ISBT 128 Standards Documents - 03 October 2014

 

Technical Specification

The Technical Specification is the “master document” for ISBT 128. The document provides the specifications for coding information using ISBT 128. It outlines how data structures should be encoded and interpreted. Also, it provides the general requirements for labeling of medical products of human origin (MPHO) using ISBT 128.

ST-001 ISBT 128 Standard: Technical Specification Version 5.1.0 – PDF (1 MB)

 

Standard Terminology

To achieve standardization, ISBT 128 uses internationally agreed upon product definitions. This document is updated and given a new version number each time there is a change to the Class or Attribute tables of the ISBT 128 Product Description Codes Database. It contains the formal definitions of all Classes, Modifiers, and Attributes used in the database. The default value for each Attribute group is also specified in the document. 

*Version 5.4   

ST-002 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions – PDF (963 kB)

Standard Terminology Version Control Sheet 2014 – PDF (168 kB)

Standard Terminology Version Control Sheet 2013 – PDF
Standard Terminology Version Control Sheet 2012 – PDF    
Standard Terminology Version Control Sheet 2011 – PDF
Standard Terminology Version Control Sheet (Prior to 2011) – PDF

 

Standards Documents

Below are the ISBT 128 standards documents. Scroll down or click on a link to go to a particular document.

 

Standard Labeling - Tissues

ST-003 ISBT 128 Standard Labeling of Human Tissues v1.0.0 - PDF (473 kB)

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This document provides a labeling guideline for ISBT 128 tissues products. Greater detail is given for labeling than that provided in the Technical Specification.

 

Standard Labeling - Cellular Therapy

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0 - PDF (955 kB)

This document provides a labeling guideline for ISBT 128 cellular therapy products. Greater detail is given for labeling than that provided in the Technical Specification.

 

Standard Labeling - Blood

ST-005 ISBT 128 Standard Labeling of Blood Components v1.0.0 - PDF (826 kB)

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This document provides a labeling guideline for ISBT 128 blood components. Greater detail is given for labeling than that provided in the Technical Specification.

 

Standard Labeling - Ocular Tissues

ST-009 ISBT 128 Standard Labeling of Ocular Tissue v1.0.0 - PDF (494 kB)

This document provides a labeling guideline for ISBT 128 ocular tissues. Greater detail is given for labeling than that provided in the Technical Specification.

 

Product Description Code Database

ST-010 ISBT 128 Standard Product Description Code Database v6.0.0 - PDF (378 kB)

This document provides the specifications for each of the tables that make up the new database and it explains the relationships between the tables.

 

Standard Coding and Labeling - Medical Devices

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.2.0 - PDF (904 kB)

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard.

This document is a supplement to the ISBT 128 Standard Technical Specification. It provides specific requirements and guidance for facilities labeling medical devices that contain human cells, tissues, or cellular or tissue-based products (HCT/P) that are regulated as medical devices.